Background: Numerous randomized controlled trials (RCTs) both inside and outside of the Veterans Health Administration (VHA) have demonstrated the efficacy of smoking cessation pharmacotherapies. Hence, both inside and outside the VHA, there has been wide-scale distribution of smoking cessation pharmacotherapies including the implementation of VHA directive 2003-042, National Smoking and Tobacco Use Cessation Program, which indicates that cessation medications need to be made available to all smokers interested in quitting, regardless of whether or not the patient is willing to attend a cessation program. Despite the broad distribution of these smoking cessation pharmacotherapies, declines in adult smoking prevalence have stalled in the past 5 years, one in five adults continues to smoke, and this is true in the VHA as well. Recently outside the VHA, the generalizability of RCT results to the community setting has been challenged, as cross-sectional population studies have shown lower risk of relapse among persons not using cessation pharmacotherapies. The quit rates of the wide-scale distribution of cessation pharmacotherapies in the VHA are unknown. Objectives: Using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework as a guide, the objectives of this study are to: 1) Determine the reach of smoking cessation pharmacotherapies (percentage of smokers that receive smoking cessation pharmacotherapies over a ten-year period, trends over time, and patient-level factors associated with receipt of these smoking cessation pharmacotherapies); 2) Using health factors data, determine the effectiveness of smoking cessation pharmacotherapies by comparing quit rates among those who receive and do not receive specific smoking cessation pharmacotherapies; 3) Determine adoption by identifying the proportion of providers, clinics, and facilities prescribing smoking cessation pharmacotherapies; 4) Determine the cost per quit of implementing smoking cessation pharmacotherapies; and 5) Based on the findings, make recommendations on the maintenance of the program. Methods: Using pharmacy data and data from the electronic medical record stored in the VHA's Corporate Data Warehouse (CDW), this will be a cohort study of Veteran smokers. The reach of smoking cessation pharmacotherapies prescribed will be abstracted from the CDW data. Smoking quit rates (effectiveness) will be identified from the health factors data and using marginal structural models to control for selection bias, we will compare quit rates among smokers who were and were not prescribed smoking cessation pharmacotherapies, quit rates among subgroups of smokers (e.g., gender and comorbidities), and changes in quit rates over time. The pharmaceutical cost per quit will be determined by dividing the costs of the smoking cessation pharmacotherapies distributed by the number of quits. Recommendations for maintaining the program will be made based on the results of this study. Conclusion: Evaluating the reach, effectiveness, implementation, and adoption of smoking cessation pharmacotherapies has critical implications for VHA guidelines regarding the maintenance of the program.